The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 [ Time Frame: Baseline and Visit 8 Which Spans Weeks 11/12 ] [ Designated as safety issue: No ]

Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.

Secondary Outcome Measures:

Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Percent of Participants With a 4-Week Cessation From Binge Eating [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.

The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.

Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]

Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]

Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]

The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.

Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]

The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01718509